Whitepapers

In this white paper, we zoom out with a broader lens to view serialization as part of a broader system to ensure safety in pharmaceuticals.

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet 3D-printing enables advanced process analytics, tablet-level traceability, and continuous monitoring to provide a data-driven approach to pharmaceutical production. By measuring critical quality attributes for every tablet throughout manufacturing, the platform enables continuous process verification, targeted identification of deviations, and reduced waste compared with traditional batch-based quality methods. This integrated foundation supports real-time release while delivering greater transparency, process control, and operational efficiency across the product lifecycle.

Sequence variant analysis is essential for characterizing biotherapeutic proteins, but high rates of false positives can slow development. Subtle yet potentially profound changes to a protein's amino acid sequence can dramatically alter its function and impact patient safety. This paper reveals how low-level posttranslational modifications introduced during protein digestion can be misidentified as sequence variants. By implementing time-course digestion during method development, it can effectively distinguish true variants from artifacts, significantly reducing data analysis time. Case studies also show how to integrate time-course digestion into a workflow.

Liquid nasal drug delivery has evolved from simple local therapies into a highly versatile platform supporting rapid systemic delivery, emergency rescue medications, and emerging CNS-targeted treatments. As these applications expand, successful development increasingly depends on early, integrated alignment of formulation science, device selection, analytical control, and manufacturing strategy. In this article, Catalent experts Dr. Alan Watts and David Wilcox examine the current and emerging nasal delivery landscape and outline critical chemistry, manufacturing, and controls (CMC) considerations across development, scale-up, and commercial production. Drawing on real-world experience, the piece highlights practical strategies to reduce technical risk, support regulatory readiness, and enable robust, scalable liquid nasal drug products.

Poor solubility remains one of the most persistent and costly challenges in pharmaceutical drug development. Inside this eBook you'll find peer-reviewed research and expert perspectives on how AI, machine learning, and molecular dynamics simulations are transforming cyclodextrin-based drug formulation. From a novel nomenclature system that enables AI-driven structural optimization to a landmark case study examining remdesivir's interactions with sulfobutylether-β-cyclodextrins, readers will gain actionable insight into predictive modeling strategies that reduce API waste, accelerate development timelines, and improve the odds of getting complex small molecules to patients.

Discover the benefits of a global CDMO manufacturing strategy built for scale, speed and reliability

See how early supply chain engagement and continuous improvement reduce risk, accelerate tech transfer and time-to-market, and ensure reliable supply for customers and patients—download the white paper to learn more.

Biologics manufacturing is shifting toward integrated ecosystems that align clinical and commercial needs within a unified operational model. Learn how to deliver speed, flexibility, and lifecycle efficiency from early clinical supply to high-volume commercial production.

MaxiPure® Polysorbate 80 is a highly pure excipient designed for high-value injectable applications where control of particles, oxidative stress, and biological compatibility is essential. Fully compliant with Ph. Eur., USP-NF, JP and CP monographs, this non-ionic surfactant is characterized by an oleic acid content above 98%, exceptionally low impurity levels, and outstanding clarity. By combining regulatory excellence with functional performance, MaxiPure® Polysorbate 80 supports the development of stable and safe protein-based therapeutics, and ensures formulation reliability across the drug development lifecycle.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

The manufacturing landscape is evolving rapidly, marked by ever-increasing competition and consumer demands, unpredictable supply chain disruptions, and the persistent challenge of employee turnover. Optimizing processes and tightening production efficiency has become a top priority for manufacturers across the process industries. Among these processes, efficient mixing stands out as a cornerstone of production, affecting energy consumption, product quality, and operational costs. Yet despite its pivotal role, the benefits of mixing are often underestimated. This article presents five possible strategies that manufacturers can begin to adopt.

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

Discover the four major hidden cost centers teams tend to overlook when it comes to paper logbooks, along with a real world example showing what happens when a site replaces paper with digital

This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization.

Microbial cell culture processes are diverse and difficult to harmonize, however, with a new microbial purification platform, downstream processes are streamlined. Applicable for use in E. coli and P. pastoris, this microbial purification platform utilizes a novel scarless protease to reduce purification steps, accelerating the journey from PD to GMP.

Discover how a “Predict-First” approach uses AI-driven in silico models to de-risk mAb development. See real-case results and a manufacturability scoring framework that accelerates decisions and speeds therapies to market.

One of the biggest challenges in pharma production is cohesive, incompatible, or otherwise difficult-to-mix powders. Luckily, mixing technology is advancing and innovative solutions exist to overcome nearly all challenges.